NCT01388556

Brief Summary

Exercise is often noted as an important component in a comprehensive approach to the management of Parkinson disease (PD). Most studies of exercise have examined the effects of short-term interventions and have tested participants on their anti-Parkinson medications. As such, these studies have not been able to determine whether or not exercise may have a disease-modifying effect in people with PD. The investigators recent work has shown the potential benefits of dance as a form of exercise for individuals with PD, but, like previous work, has only examined short-term interventions. The investigators think that dance may be ideally suited for study over a longer period of time because dance incorporates many of the features recommended for inclusion in PD-specific exercise programs in a format that is known to be engaging and to enhance motivation to participate in healthful behaviors. As such, the investigators aim to determine both the short- and long-term effectiveness of a community-based dance program for individuals with Parkinson disease and to determine how physical function changes over time in individuals with PD who do not exercise as compared to those who exercise regularly. The investigators hypothesize that: A) participation in dance will result in improved physical function, cognitive function, mood and quality of life in people with PD within 3 months, B) additional improvements will be noted at 6 months as compared to 3 months, C) improvements will be maintained at one year with continued, regular participation in a dance class, D) those who do not exercise will show significant functional decline over a period of one year, a decline that will not be present in those who dance regularly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

June 29, 2011

Last Update Submit

December 7, 2015

Conditions

Keywords

exerciseParkinson diseasemotor symptomsgaitbalance

Outcome Measures

Primary Outcomes (1)

  • Motor Symptom Severity

    We will use the Unified Parkinson Disease Rating Scale, Motor Subscale 3, to assess the severity of movement-related symptoms. This is a standanrdized and well-established tool composed of multiple items each scored on a 0-4 scale, with 0 indicating no impairment and 4 indication severe impairment. The overall severity of motor symptoms is determined by summing scores for all of the individual items.

    12 months

Study Arms (2)

Tango

EXPERIMENTAL

Twice weekly tango dance classes for 12 months.

Behavioral: Tango dancing

Control Group

NO INTERVENTION

Interventions

Tango dancingBEHAVIORAL

Twice weekly tango dance classes

Tango

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal central and peripheral neurological function
  • at least grade 4/5 strength and normal joint ranges of motion in both legs, - vision corrected to 20/40 or better
  • able to walk independently for 10 feet with or without an assistive device, - normal somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch)
  • no history of vestibular disease

You may not qualify if:

  • serious medical problem
  • evidence of abnormality other than PD-related changes on brain imaging (previously done for clinical evaluations-not part of this research)
  • history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease
  • history or evidence of orthopedic, muscular, or psychological problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (3)

  • Duncan RP, Earhart GM. Measuring participation in individuals with Parkinson disease: relationships with disease severity, quality of life, and mobility. Disabil Rehabil. 2011;33(15-16):1440-6. doi: 10.3109/09638288.2010.533245. Epub 2010 Nov 20.

    PMID: 21091047BACKGROUND
  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 6, 2011

Study Start

July 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations